Minerva’s MIN-117 for MDD raises expert doubts on efficacy, onset and safety as positive topline release appears to misrepresent Phase IIa results, experts say

16 Nov 2018

Minerva Neurosciences (NASDAQ:NERV) has experts questioning MIN-117’s efficacy and safety profile in major depressive disorder (MDD) after discerning that positive topline results from two years ago do not accurately reflect non-statistically significant results emerging after a full analysis.

The company announced on 26 May 2016 that the 84-patient trial (2015-000306-18) had positive topline results, demonstrating dose-dependent superiority of MIN-117 over placebo in its primary endpoint of Montgomery-Asberg Depression Rating Scale (MADRS), with improvement over placebo observed at two weeks. Both 0.5mg and 2.5mg doses were described to have effect size magnitudes of 0.23 and 0.33 respectively, similar to currently marketed antidepressants. Minerva share prices were up 233% as a result. Yet on the EU Clinical Trials Register, the primary MADRS endpoint at six weeks and secondary MADRS endpoint at two weeks, in addition to other secondary endpoints, were not statistically significant.

Some experts said that MIN-117’s initial data might have been painted in a more positive light than it actually was, after looking at the full data analysis from the EU Clinical Trials Register. It is also hard to know whether the claims of MIN-117 lacking typical antidepressant side effects could be true given current data, experts noted.

Analysts have not picked up on this data discrepancy, as reports describe Phase IIa results as positive, even statistically significant, lending optimism for Phase IIb results. Analyst commentary focuses on MIN-117’s effect size appearing similar to currently marketed antidepressants, showing favorable safety in sleep endpoints and supposed quick onset at two weeks. They note that if MIN-117 captures 5% of the MDD market, sales could be roughly USD 1.6bn in the US alone. Minerva has a market cap of USD 319m.

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